Vascular and Endovascular Surgery最新文献

{"title":"Hyperbaric Oxygen as an Adjunct in the Treatment of Venous Ulcers: A Systematic Review.","authors":"Colum Keohane,&nbsp;Daniel Westby,&nbsp;Fiona C Nolan,&nbsp;Mark Twyford,&nbsp;Wael Tawfick,&nbsp;Stewart R Walsh","doi":"10.1177/15385744231162924","DOIUrl":"https://doi.org/10.1177/15385744231162924","url":null,"abstract":"<p><strong>Background: </strong>The use of Hyperbaric Oxygen Therapy (HBOT) in diabetic wounds has been studied extensively. Even though venous insufficiency is the most common cause of lower limb ulceration, there is comparatively little evidence regarding the use of HBOT for Venous Leg Ulcers (VLU). We performed a systematic-review to evaluate and synthesise available evidence, to evaluate whether patients with VLU, when treated with HBOT, had greater rates of (i) complete VLU healing or (ii) reduction in VLU area, than controls.</p><p><strong>Methods: </strong>In keeping with PRISMA guidelines, database searches of PubMed, Scopus and Embase was performed. After removal of duplicates, titles were screened for relevance by two authors, then abstracts, and in turn full text manuscripts. Data were extracted from relevant sources including one published abstract. Included studies were assessed for risk of bias using the Risk of Bias 2 (RoB-2) and Risk Of Bias In Nonrandomized Studies (ROBINS-I) tools.</p><p><strong>Results: </strong>Six studies were included. There was significant heterogeneity across the studies, with no standard control intervention, method of outcome reporting, or duration of follow up. Two studies reported 12 week follow up results and pooled analysis of complete ulcer healing showed no statistically significant difference between HBOT and controls for the outcome of complete ulcer healing OR 1.54 (95%CI = .50-4.75) P = .4478. A similar non-signifiacnt result was seen in four studies reporting 5-6 week follow up; OR 5.39 (95%CI = .57-259.57) P = .1136. Change in VLU area was reported in all studies, and pooled standardised mean difference was 1.70 (95%CI = .60 to 2.79) P = .0024, indicating a statistically significant benefit of HBOT in reducing ulcer area.</p><p><strong>Conclusion: </strong>Existing evidence suggests that HBOT does not significantly affect complete healing of VLU. There is a statistically significant benefit in terms of reducing ulcer size, though in the absence of ulcer healing the clinical significance of this is not established. Current evidence does not justify widespread use of HBOT for VLU.</p>","PeriodicalId":23530,"journal":{"name":"Vascular and Endovascular Surgery","volume":null,"pages":null},"PeriodicalIF":0.9,"publicationDate":"2023-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10291374/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10081643","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Cystic Adventitial Disease of the Common Femoral Vein Presenting with Lower Limb Swelling: A Case Report.","authors":"Yang Liu,&nbsp;Qiqi Wang,&nbsp;Chunshui He","doi":"10.1177/15385744231165991","DOIUrl":"https://doi.org/10.1177/15385744231165991","url":null,"abstract":"<p><p>Cystic adventitial disease (CAD) is a rare vascular disorder predominantly seen in adults without cardiovascular risk factors. We report a case of CAD involving the common femoral vein in a 38-year-old female presented with right lower extremity swelling that was initially misdiagnosed as deep vein thrombosis (DVT). A computed tomography revealed a cystic structure that compressed the right common femoral vein with resultant severe stenosis of the vascular lumen. Complete evacuation of the cyst with excision of the cyst wall was performed, and the patient remained symptom-free at 3 year follow-up. This case highlighted that the rare venous CAD should be incorporated in the differential diagnosis of unilateral lower extremity swelling suspicious for a DVT. Complete evacuation and surgical excision of the cyst often conferred favorable clinical outcome.</p>","PeriodicalId":23530,"journal":{"name":"Vascular and Endovascular Surgery","volume":null,"pages":null},"PeriodicalIF":0.9,"publicationDate":"2023-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9680295","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Endovascular Repair of Iatrogenic Inferior Vena Cava and Iliac Vein Injury: A Case Series and Review of the Literature.","authors":"Laura Pride,&nbsp;Kierney Jackson,&nbsp;Jonathan Woody,&nbsp;Christopher Everett","doi":"10.1177/15385744231163964","DOIUrl":"https://doi.org/10.1177/15385744231163964","url":null,"abstract":"<p><strong>Objective: </strong>Iatrogenic injury to the large abdominopelvic veins can he highly morbid, and open surgical repair is technically challenging. Endovascular repair with covered stenting across the injured segment offers an alternative to open surgical management. We present a series of patients with operative injury to the inferior vena cava (IVC) and iliac veins who were treated utilizing an endovascular approach and review the available literature on this technique.</p><p><strong>Methods: </strong>A PubMed keyword and MeSH term search was performed, and titles were reviewed for relevance by the first author. Studies related to endovascular repair of iatrogenic injury to the IVC and iliac veins were then read in detail for possible inclusion in the review. Those deemed appropriate were further analyzed for interventional approach, stent type and size, technical success, post-procedural pharmacologic management, complications and surveillance strategy.</p><p><strong>Results: </strong>The initial search resulted in 6221 publications. A total of 17 met criteria for inclusion, all of which were case reports or series. Twenty-six patients were described as suffering iatrogenic injury to the IVC or iliac veins, treated with various types and sizes of stents. All cases achieved technical success with hemorrhage control. Procedural complications occurred in 15.4% of cases, including 3 cases of acute thrombus formation and 1 case of stenosis caudal to the initial stent edge requiring additional stenting. Two additional patients experienced stent occlusion in the surveillance period.</p><p><strong>Conclusions: </strong>Endovascular repair of iatrogenic injury to the IVC and iliac veins can be an effective management option. However, due to limited data regarding this approach, many technical questions remain, including ideal size and type of stent graft, necessity and duration of post-procedural anticoagulant or antiplatelet therapy and appropriate surveillance. Additionally, long term outcomes in this population have not yet been described.</p>","PeriodicalId":23530,"journal":{"name":"Vascular and Endovascular Surgery","volume":null,"pages":null},"PeriodicalIF":0.9,"publicationDate":"2023-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9685553","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Readmission After COVID-19 for Late Acute Venous Thrombosis; CASE SERIES and Systematic Review of the Literature.","authors":"Oliver Antonio Gómez Gutiérrez,&nbsp;Gabriel Salinas McQuary,&nbsp;Mauricio Gonzalez-Urquijo,&nbsp;Gerardo Lozano Balderas,&nbsp;Mario Alejandro Fabiani","doi":"10.1177/15385744231163976","DOIUrl":"https://doi.org/10.1177/15385744231163976","url":null,"abstract":"<p><strong>Objective: </strong>Assess heterogeneity within patients with resolved COVID-19 to broaden the vision about post-discharge thrombotic cases and postulate possible related mechanisms in search of better anticoagulation guidelines. This study details patients' characteristics, medical history, treatment, and outcomes of readmitted patients with late acute thrombosis through a systematic review of the literature and patients from our academic center database.</p><p><strong>Methods: </strong>We extracted the records of patients readmitted for venous thrombosis complications after discharge from the database of the first 2000 patients admitted with COVID-19 in our academic center; we also performed a systematic review of the literature using the Medical Subject Headings terms \"late thrombosis,\" \"COVID-19,\" + \"venous thrombosis\" in PubMed and Google Scholar according to PRISMA guideline.</p><p><strong>Results: </strong>The literature review found 20 patients suitable for review matching the inclusion criteria. These patients were added to those in our database, summing up a total of 26 patients. The median age was 50 years old, 76.9% were male, and most were overweight or had grade 1 obesity (n = 11, 42.3%). None had a previous thrombotic history, but 50% had an underlying comorbidity. Thrombotic events presented on a median of 20 days (range: 4-150 days) from discharge. Pulmonary embolisms occurred in 23 patients (88.46%), deep vein thrombosis in 4, mesenteric thrombosis, and cerebral venous thrombosis in 1, respectively.</p><p><strong>Conclusion: </strong>This study found that most patients readmitted for thrombotic events after COVID-19 discharge were middle-aged men with Venous Thrombo Embolism events.</p>","PeriodicalId":23530,"journal":{"name":"Vascular and Endovascular Surgery","volume":null,"pages":null},"PeriodicalIF":0.9,"publicationDate":"2023-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9680287","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Predictors for Distal Revascularization Following Femoral Endarterectomy in Chronic Limb-Threatening Ischemia Patients.","authors":"Khaled I Alnahhal,&nbsp;Hassan Dehaini,&nbsp;Ahmed A Sorour,&nbsp;Priyam Vyas,&nbsp;Maryana Chumakova,&nbsp;James Bena,&nbsp;Lee Kirksey","doi":"10.1177/15385744231154084","DOIUrl":"https://doi.org/10.1177/15385744231154084","url":null,"abstract":"<p><strong>Objective: </strong>This study aims to identify the clinical variables which are predictive for the benefit of concomitant distal revascularization (DR) to prevent Chronic limb-threatening ischemia (CLTI) progression and the need for major limb amputation.</p><p><strong>Methods: </strong>This is a retrospective cohort study of patients who presented with lower limb ischemia and required at least femoral endarterectomy (FEA), recruited over a period of 15 years (2002-2016). The patient cohort was divided into three groups based on the type of intervention: A (FEA alone), B (FEA + catheter-based intervention/(CBI)), and C (FEA + surgical bypass (SB)). The primary endpoint was to identify independent predictors for the use of concomitant DR (CBI or SB). Secondary endpoints were amputation rate, length of stay, mortality rate, postoperative ankle-brachial index and complications, readmission rate, re-intervention rate, resolution of symptoms and wound status.</p><p><strong>Results: </strong>A total of 400 patients were included, 68.0% were males. Most presenting limbs were at Rutherford class (RC) III and WIfI stage 2, with an ankle-brachial index (ABI) of .47 ± .21 and a TASC II class C lesion. No significant differences were found in the primary-assisted and secondary patency rates between the three groups (<i>P</i> > .05, in all). In the multivariate analyses, clinical variables associated with DR were hyperlipidemia (hazard ratio (HR) 2.1-2.2), TASC II D (HR 2.62), Rutherford class 4 (HR 2.3) and 5 (HR 3.7), as well as WIfI stage ≥3 (HR 1.48).</p><p><strong>Conclusions: </strong>Femoral endarterectomy is sufficient to treat intermittent claudication. However, patients in whom rest pain, tissue loss or TASC II D anatomic lesion severity are present may benefit from concomitant distal revascularization. Taking into consideration the overall assessment of operative risk factors for each individual patient, proceduralists should have a lower threshold for performing early or concomitant distal revascularization to reduce CLTI progression including additional tissue loss and/or major limb amputation.</p>","PeriodicalId":23530,"journal":{"name":"Vascular and Endovascular Surgery","volume":null,"pages":null},"PeriodicalIF":0.9,"publicationDate":"2023-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9735708","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"N-butyl-2-cyanoacrylate Packing of a Gastroduodenal Artery Pseudoaneurysm due to Distal Pancreatectomy After Subtotal Esophagectomy.","authors":"Eisuke Shibata,&nbsp;Hidemasa Takao,&nbsp;Osamu Abe","doi":"10.1177/15385744231165207","DOIUrl":"https://doi.org/10.1177/15385744231165207","url":null,"abstract":"<p><p>We describe the successful <i>n</i>-butyl cyanoacrylate (NBCA) packing of a large gastroduodenal artery pseudoaneurysm after distal pancreatectomy in a patient with a history of subtotal esophagectomy and gastric tube reconstruction. The pseudoaneurysm was considered to be caused by direct injury to the gastroduodenal artery (GDA). However, embolization of the GDA was not possible in this case because due to prior esophageal surgery, the main blood vessel supplying the gastric tube was the right epigastric artery from the GDA. Packing a pseudoaneurysm with NBCA is a treatment option when preservation of the parent artery is required.</p>","PeriodicalId":23530,"journal":{"name":"Vascular and Endovascular Surgery","volume":null,"pages":null},"PeriodicalIF":0.9,"publicationDate":"2023-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9673386","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Specialty Balloons for Vessel Preparation During Infrainguinal Endovascular Revascularization Procedures: A Review of Literature.","authors":"Stefanos Giannopoulos,&nbsp;Panagiotis Volteas,&nbsp;Dimitrios Virvilis","doi":"10.1177/15385744231156077","DOIUrl":"https://doi.org/10.1177/15385744231156077","url":null,"abstract":"<p><p>Balloon angioplasty with/without utilizing drug eluting technology or stenting constitutes the treatment of choice for a significant percentage of patients with peripheral artery disease requiring an intervention. However, in cases of diffuse disease and plaque complexity, angioplasty may lead to dissection, recoil, and/or early restenosis, making vessel preparation a key component for successful and durable endovascular revascularization outcome. This review of literature aims to present contemporary data for several commercially available specialty balloons that have been designed to minimize the arterial wall stress of conventional balloon angioplasty and facilitate technical success, as well as long-term patency.</p>","PeriodicalId":23530,"journal":{"name":"Vascular and Endovascular Surgery","volume":null,"pages":null},"PeriodicalIF":0.9,"publicationDate":"2023-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9681246","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Contrast-Associated Acute Kidney Injury in High-Risk Patients Undergoing Peripheral Vascular Interventions.","authors":"Satinderjit Locham,&nbsp;Alejandra Rodriguez,&nbsp;Mark D Balceniuk,&nbsp;Doran Mix,&nbsp;Karina Newhall,&nbsp;Adam Doyle,&nbsp;Roan Glocker,&nbsp;Jennifer Ellis,&nbsp;Michael Stoner","doi":"10.1177/15385744231162941","DOIUrl":"https://doi.org/10.1177/15385744231162941","url":null,"abstract":"<p><p><b>Objective:</b> This study aims to evaluate the use of prophylactic intravenous hydration (IV prophylaxis) and carbon dioxide (CO₂) angiography in reducing contrast associated-acute kidney injury (CA-AKI) and determine the overall incidence and risk factors of CA-AKI in high-risk patients undergoing peripheral vascular interventions (PVI). <b>Method:</b> Only patients undergoing elective PVI from 2017 to 2021 with chronic kidney disease (CKD) stage 3-5 in the Vascular Quality Initiative (VQI) database were included. Patients were grouped into IV prophylaxis vs no prophylaxis. The study's primary outcome was CA-AKI, defined as a rise in creatinine (>.5 mg/dL) or new dialysis within 48 hours following contrast administration. Standard univariate and multivariable (logistic regression) analyses were conducted. <b>Results:</b> A total of 4497 patients were identified. Of these, 65% received IV prophylaxis. The overall incidence of CA-AKI was .93%. No significant difference was seen in overall contrast volume (mean (SD): 66.89(49.54) vs 65.94(51.97) milliliters, <i>P</i> > .05) between the 2 groups. After adjusting for significant covariates, the use of IV prophylaxis (OR (95% CI): 1.54(.77-3.18), <i>P</i> = .25) and CO₂ angiography (OR (95%CI): .95(.44-2.08), <i>P</i> = .90) was not associated with a significant reduction in CA-AKI compared to the patients with no prophylaxis. The severity of CKD and diabetes were the only predictor of CA-AKI. Compared to patients with no CA-AKI, patients with CA-AKI were at risk of higher 30-day mortality (OR (95% CI): 11.09 (4.25-28.93)) and cardiopulmonary complications (OR (95% CI): 19.03 (8.74-41.39) following PVI (Both <i>P</i> < .001). <b>Conclusion</b><b>:</b> Using a large national vascular database, our study demonstrates that prophylactic use of IV hydration and CO₂ angiography in high-risk CKD patients is not associated with a reduction in renal injury following PVI. Reduced kidney function and history of diabetes is an independent predictor of CA-AKI and patients that develop post-procedural AKI are at an increased risk of morbidity and mortality.</p>","PeriodicalId":23530,"journal":{"name":"Vascular and Endovascular Surgery","volume":null,"pages":null},"PeriodicalIF":0.9,"publicationDate":"2023-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9681761","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Spontaneous Iliac Vein Ruptures: A Systematic Review.","authors":"Alexander L Kooiman,&nbsp;Jay M Bakas,&nbsp;Joris M K van Fessem,&nbsp;Willem P A Boellaard,&nbsp;Sandra A P Cornelissen,&nbsp;Marie Josee E van Rijn","doi":"10.1177/15385744231163707","DOIUrl":"https://doi.org/10.1177/15385744231163707","url":null,"abstract":"<p><strong>Introduction: </strong>Spontaneous iliac vein rupture is a rare, but frequently lethal condition. It is important to timely recognize its clinical features and immediately start adequate treatment. We aimed to increase awareness to clinical features, specific diagnostics, and treatment strategies of spontaneous iliac vein rupture by evaluating the current literature.</p><p><strong>Methods: </strong>A systematic search was conducted in EMBASE, Ovid MEDLINE, Cochrane, Web of Science, and Google Scholar from inception until January 23, 2023, without any restrictions. Two reviewers independently screened for eligibility and selected studies describing a spontaneous iliac vein rupture. Patient characteristics, clinical features, diagnostics, treatment strategies, and survival outcomes were collected from included studies.</p><p><strong>Results: </strong>We included 76 cases (64 studies) from the literature, mostly presenting with left-sided spontaneous iliac vein rupture (96.1%). Patients were predominantly female (84.2%), had a mean age of 61 years, and frequently presented with a concomitant deep vein thrombosis (DVT) (84.2%). After various follow-up times, 77.6% of the patients survived, either after conservative, endovascular, or open treatment. Endovenous or hybrid procedures were frequently performed if the diagnose was made before treatment, and almost all survived. Open treatment was common if the venous rupture was missed, for some cases leading to death.</p><p><strong>Conclusion: </strong>Spontaneous iliac vein rupture is rare and easily missed. The diagnose should at least be considered for middle-aged and elderly females presenting with hemorrhagic shock and concomitant left-sided DVT. There are various treatment strategies for spontaneous iliac vein rupture. An early diagnose brings options for endovenous treatment, which seems to have good survival outcomes based on previously described cases.</p>","PeriodicalId":23530,"journal":{"name":"Vascular and Endovascular Surgery","volume":null,"pages":null},"PeriodicalIF":0.9,"publicationDate":"2023-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10291386/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9705073","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Two-Year Results of a First-In-Human Study in Patients Surgically Implanted With a Bioprosthetic Venous Valve, the VenoValve in Patients With Severe Chronic Venous Insufficiency.","authors":"Jorge H Ulloa,&nbsp;Sebastian Cifuentes,&nbsp;Valentin Figueroa,&nbsp;Marc Glickman","doi":"10.1177/15385744231155327","DOIUrl":"https://doi.org/10.1177/15385744231155327","url":null,"abstract":"<p><strong>Objective: </strong>Two-year follow-up results from a first-in-human study of patients implanted with the VenoValve are evaluated for supporting the long-term clinical safety and performance of the device.</p><p><strong>Background: </strong>Chronic Venous Insufficiency (CVI) involves improper functioning of lower limb vein valves and inability of these valves to move blood back towards the heart. CVI symptoms include swelling, varicose veins, pain, and leg ulcers. Currently, there is no cure for this condition and treatment options are limited. This study provides 2-year outcomes for 8 patients who were implanted with the bioprosthetic VenoValve for treating severe CVI with deep venous reflux measured at the mid-popliteal vein. The 6-month and 1-year results were previously published.</p><p><strong>Methods: </strong>Eleven patients with C5 & C6 CVI were implanted with VenoValve into the midthigh femoral vein and followed for 2 years. Assessed clinical outcomes include device-related adverse events, reflux time, disease severity, and pain scores.</p><p><strong>Results: </strong>All 11 implant procedures were successful. Two-year follow-up data was obtained for 8 subjects: 1 patient died of non-device related causes, 1 was lost to follow-up, and 1 refused to follow-up due to the COVID-19 pandemic. No device-related adverse events occurred between the first and second years of follow-up. Reported 2-year clinical performance outcomes included significant decreases in mean reflux times of the mid-popliteal vein (61%), and significant improvements in mean scores for disease severity rVCSS (56%) and VAS pain (87%).</p><p><strong>Conclusions: </strong>Results from this study support long-term safety and effectiveness of the VenoValve for improving CVI severity by reducing reflux and thereby venous pressures in the lower extremities. With limited treatments for valvular incompetence involved in severe, deep venous CVI, the device may be considered as a novel therapy. A pivotal trial in the United States is currently being conducted to assess the device in a larger number of patients.</p>","PeriodicalId":23530,"journal":{"name":"Vascular and Endovascular Surgery","volume":null,"pages":null},"PeriodicalIF":0.9,"publicationDate":"2023-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10055618","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}